By Ed Susman
SAN FRANCISCO -- September 17, 2009 -- Patients with HIV who have oral yeast complications can achieve relief with a once-daily miconazole mucoadhesive buccal tablet -- replacing a multiple-pill daily-treatment regimen, researchers suggested at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Oral candidiasis occurs in about one-third to one-half of HIV patients and up to 90% of AIDS patients. It is also common in patients suffering from many forms of cancer, especially those with head and neck cancer, in which the infection rate is as high as 77%.
"This is an exciting, new, convenient way for treating this infection," said lead investigator Jose A. Vazquez, MD, Henry Ford Hospital, Detroit, Michigan, presenting his findings here at a poster presentation on September 14. "It's a tablet that you just stick on the gum and it releases an anti-fungal agent over the course of 6 to 7 hours. Because the anti-fungal agent stays in the mouth, it provides the same relief as the oral medication, but with few or no side effects."
Dr. Vasquez and colleagues undertook a study to examine the effectiveness and safety of taking a 50-mg miconazole mucoadhesive buccal tablet once daily (n = 291) compared with taking clotrimazole 10 mg 5 times per day (n = 287).
In the intention-to-treat population, clinical cure rates among the patients receiving the miconazole tablet were not statistically different than those receiving clotrimazole. About 61% of the miconazole-treated patients achieved a cure for their yeast infection compared with 65% of the clotrimazole-treated patients.
Dr. Vazquez reported that in the per-protocol population, clinical success was achieved by 65% of the miconazole-treated patients and versus 69% of those receiving clotrimazole. He said that difference, again, did not achieve statistical significance. Mycological cure was achieved by 27.2% of the miconazole-treated group and 24.7% of those on clotrimazole -- again not statistically different.
"The once-daily application of miconazole 50-mg buccal tablets was as efficacious as clotrimazole 10-mg troches 5 times a day for oral candidiasis treatment in HIV/AIDS patients," said Dr. Vazquez. "The buccal tablet offers an effective alternative for the treatment of oral candidiasis, with the added convenience of once-a-day dosing and minimal adverse events."
The study is believed to be the largest to date involving patients with HIV/AIDS and oral candidiasis.
Funding for this study was provided by BioAlliance Pharma.
[Presentation title: A Multicenter, Randomized Trial Evaluating the Efficacy and Safety of Miconazole Mucoadhesive Buccal Tablets (MMBT) Versus Clotrimazole Troches (CT) for the Treatment of Oropharyngeal Candidiasis (OPC) in Subjects With HIV/AIDS: SMiLES Trial. Abstract M-1245]
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